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“We Can’t Ignore It:” Former FDA Official on Social Media for Pharmacovigilance

Posted April 5, 2016

Former FDA Associate Commissioner Peter J. Pitts recently shared his thoughts on social media and postmarketing surveillance. His statements reflect an emerging consensus about pharmacovigilance and the need to strengthen the industry’s ability to identify important drug safety signals from the rich stream represented by social media.

First, he outlines the shortcomings of the existing system:

The general consensus is that MedWatch captures around 10 percent of adverse events. That’s probably high. But even if it’s accurate, it’s remarkably and dangerously low.

Then he goes on to highlight some of the challenges related to social media:

There are a lot of ways to collect data. Social media is one that has caused problems. The signal to noise ratio issues are profound, but we can’t ignore it because within all that noise there are gems that we must capture. The challenge is how to put robust modern pharmacovigilance or pharmacoepidemiology programs in place for established drugs and decide who leads the effort. We need to do a better job of capturing and sharing data in real time. This requires better staffing and an openness to finding new things.

Pitts also sees the link between advanced PV capabilities and other parts of the business:

If we want to bring drugs to market faster, with truncated clinical trials, we’re going to need a much more robust post-marketing proposition.

There is no doubt that that the use of social media will expand in PV and other pharmaceutical functions in the coming years. But the positive change to come will start with the clear acceptance that it can’t be ignored or that it should be used only or mainly by marketing.